Green_Earth
Committee on Technical Barriers to Trade - Notification - Canada - Tramadol
日期:2021/04/07
作者:Canada
文件編號:G/TBT/N/CAN/638
附件下載:GTBTN21CAN638.pdf
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NOTIFICATION

The following notification is being circulated in accordance with Article 10.6

 

1.

Notifying Member: Canada

If applicable, name of local government involved (Article 3.2 and 7.2):

2.

Agency responsible: Health Canada

Name and address (including telephone and fax numbers, email and website addresses, if available) of agency or authority designated to handle comments regarding the notification shall be indicated if different from above:

Canada's Notification Authority and Enquiry Point
Global Affairs Canada
Technical Barriers and Regulations Division
111 Sussex Drive
Ottawa, Ontario, K1A 0G2
Canada
Tel: (343)203-4273
Fax: 613-943-0346
Email:
enquirypoint@international.gc.ca

3.

Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], other:

4.

Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): Prescription status of medicinal ingredients for human use; Other (HS 300490); Pharmaceutics (ICS 11.120)

5.

Title, number of pages and language(s) of the notified document: Notice of Intent to Amend: Prescription Drug List (PDL): Tramadol (1 page, available in English and French)

6.

Description of content: The purpose of this Notice of Intent to Amend is to notify stakeholders that Health Canada will remove tramadol from both the Human and Veterinary sections of the Prescription Drug List when the addition of tramadol to Schedule I to the Controlled Drugs and Substances Act and to the Narcotic Control Regulations comes into force on 31 March 2022. 

7.

Objective and rationale, including the nature of urgent problems where applicable: Protection of human health or safety

8.

Relevant documents:

Health Canada website for the Notice of Intent to Amend, posted 31 March 2021 (available in English and French): 

_https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/prescription-drug-list/notices-changes/intent-amendment-tramadol.html

https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/liste-drogues-ordonnance/avis-concernant-modifications/intention-modification-tramadol.html

Canada Gazette, Part II, Volume 155, 31 March 2021, pages 690-722,(available in English and French): https://canadagazette.gc.ca/rp-pr/p2/2021/2021-03-31/pdf/g2-15507.pdf

9.

Proposed date of adoption: 31 March 2021

Proposed date of entry into force: 31 March 2021

10.

Final date for comments: Non applicable

11.

Texts available from: National enquiry point [X] or address, telephone and fax numbers and email and website addresses, if available, of other body:

The electronic version of the regulatory text linked to this notice can be found at:

https://canadagazette.gc.ca/rp-pr/p2/2021/2021-03-31/html/sor-dors43-eng.html
https://canadagazette.gc.ca/rp-pr/p2/2021/2021-03-31/html/sor-dors44-eng.html
https://canadagazette.gc.ca/rp-pr/p2/2021/2021-03-31/html/sor-dors43-fra.html
https://canadagazette.gc.ca/rp-pr/p2/2021/2021-03-31/html/sor-dors44-fra.html